MVASI™ is a vascular endothelial growth factor inhibitor indicated for the treatment of: MVASI™, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first- or second-line treatment of patients with metastatic colorectal cancer... Read More
Primary endpoint: Risk ratio (RR) (90% CI)*
Predefined equivalence margin†
Risk difference (RD) (90% CI)*
Equivalence margin†
*Confidence interval (CI) is estimated using a generalized linear model adjusted for the randomization stratification factors geographic region, Eastern Cooperative Oncology Group performance status, and sex.2
†Study equivalence margins determined based on FDA guidance.3
PROVEN BIOSIMILAR TO AVASTIN® AND APPROVED FOR USE IN ALL AVAILABLE INDICATIONS1,4,‡
‡MVASI™ is not currently indicated for epithelial ovarian, fallopian tube, or primary peritoneal cancer, for which Avastin® has orphan status.5-7
Pregnancy warning
Most common adverse events
Indication-specific adverse events
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Amgen at 1-800-772-6436.
Please see full Prescribing Information for additional Important Safety Information.
MVASI™ Indications
MVASI™ is a vascular endothelial growth factor inhibitor indicated for the treatment of:
MVASI™, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first- or second-line treatment of patients with metastatic colorectal cancer.
MVASI™, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with metastatic colorectal cancer who have progressed on a first-line bevacizumab product-containing regimen.
Limitations of Use: MVASI™ is not indicated for adjuvant treatment of colon cancer.
MVASI™, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer.
MVASI™ is indicated for the treatment of recurrent glioblastoma in adults.
MVASI™, in combination with interferon-alfa, is indicated for the treatment of metastatic renal cell carcinoma.
MVASI™, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer.
Avastin® (bevacizumab) is a registered trademark of Genentech USA, Inc.
MVASI™ Important Safety Information
References: 1. Thatcher N, Goldschmidt JH, Thomas M, et al. Efficacy and safety of the biosimilar ABP 215 compared with bevacizumab in patients with advanced nonsquamous non-small cell lung cancer (MAPLE): a randomized, double-blind, phase III study. Clin Cancer Res. 2019;25:2088-2095. 2. Data on file, Amgen; 2015 [CSR 20120265]. 3. US Food and Drug Administration. FDA webinar - overview of the regulatory framework and FDA's guidance for the development and approval of biosimilar and interchangeable products in the US. www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm610901.htm. Accessed March 2, 2020. 4. MVASI™ (bevacizumab-awwb) Prescribing Information, Amgen. 5. US Food and Drug Administration. Search: orphan drug designations and approvals. www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=216405. Accessed March 2, 2020. 6. US Food and Drug Administration. Search: orphan drug designations and approvals. www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=318010. Accessed March 2, 2020. 7. US Food and Drug Administration. Search: orphan drug designations and approvals. www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=317810. Accessed March 2, 2020.